Pound: Sharapova Guilty Of 'Willful Negligence' In Drug Test; Experts Perplexed Over Why Sharapova Was Taking Banned Heart Drug

POWERED BY MELDONIUM? In this Sunday, Jan. 24, 2016, photo, Maria Sharapova of Russia celebrates after defeating Belinda Bencic of Switzerland in their fourth round match at the Australian Open tennis championships in Melbourne, Australia. (AP Photo/Aaron Favila) INSET: A box of meldonium tablets, also known as mildronate, is photographed in Moscow, Tuesday, March 8, 2016.

Maria Sharapova was guilty of "willful negligence" for using meldonium, and international tennis officials were aware that many players were taking the drug before it was banned this year, former World Anti-Doping Agency president Dick Pound said Wednesday.

Pound told The Associated Press that Sharapova could face a ban of up to four years unless she can prove mitigating circumstances to explain her positive test for meldonium at the Australian Open in January.

Meldonium, a Latvian-manufactured drug designed to treat heart conditions, was added to the World Anti-Doping Agency's banned list on Jan. 1 after authorities noticed widespread use of the substance among athletes.

In announcing her positive test at a news conference in Los Angeles on Monday, Sharapova said she had been using the drug for 10 years for various medical issues. The five-time Grand Slam champion and world's highest-earning female athlete said she hadn't realized meldonium had been prohibited this year, taking full responsibility for her mistake.

"An athlete at that level has to know that there will be tests, has to know that whatever she or he is taking is not on the list, and it was willful negligence to miss that," Pound said. "She was warned in advance I gather. The WADA publication is out there. She didn't pay any attention to it. The tennis association issued several warnings, none of which she apparently read."

"I am sorry, if you are running a US$30 million a year sole enterprise you better make sure the basis for that commercial success, if nothing else, remains unassailable," Pound added in the interview with the AP on the sidelines of the Tackling Doping in Sport conference at Twickenham Stadium.

Current WADA president Craig Reedie questioned why Sharapova was prescribed meldonium.

"If the reports are true and this was happening when she was a teenager, then you begin to wonder why a drug that is basically to help heart problems was administered," he said.

Pound disclosed that international tennis officials had flagged up the use of meldonium to the WADA committee that monitors the use of various drugs and recommends whether to put them on the banned list.

"Clearly, within the tennis circle at least, they were aware that a lot of the players were using it (meldonium) and said that there must be something to this, so they referred it to the WADA list committee," Pound said.

So far, Sharapova is the only tennis player with a known positive test for meldonium.

Meldonium, which is not approved by the U.S. Food and Drug Administration, was banned by WADA because it aids oxygen uptake and endurance. Several other athletes in various international sports have already been caught using it since it was banned Jan. 1.

A study published Wednesday in the British Journal of Sports Medicine found that up to 490 athletes may have been taking meldonium during last year's inaugural European Games in Baku, Azerbaijan. The drug was not banned at that time.

The study found that 13 winners or medalists were taking meldonium, 66 athletes tested positive for it, and the drug was detected in athletes in 15 of the 21 sports on the program. The research contributed to WADA's decision to add meldonium to the banned list.

Sharapova is being provisionally suspended by the International Tennis Federation, which will hold hearings on the case and decide on any long-term ban.

"She faces up to four years sanction for this," Pound said. "There will have to be a review of whatever mitigating factors there may be, and not many leap to mind."

Pound said he did not understand why Sharapova would have been taking the drug for so long.

The player said Monday that she had taken meldonium for a decade following various health problems including regular sicknesses, early signs of diabetes and "irregular" results from echocardiography exams.

"Looking at it from 10,000 feet and from outside, you say, 'I am sorry but that doesn't hold together,'" Pound said. "You're in the United States, this is a product that is not available in the United States, and so there has got to be more to this than meets the eye."

Grindeks, the Latvian company that manufactures meldonium, said the normal course of treatment with meldonium is four to six weeks.

"One of the issues that will have to be dealt with is that the use of this product for therapeutic purposes is not a long term," Pound said. "You use it for a single intervention for weeks or months maybe, but not for 10 years in a row."

Sharapova's lawyer, John J. Haggerty, said Tuesday that he wanted "to disabuse the concept that Maria took mildronate every day for 10 years because that's simply not the case."

Experts Perplexed Over Why Sharapova Was Taking Banned Heart Drug

Tennis star Maria Sharapova speaks during a news conference in Los Angeles on Monday, March 7, 2016. Sharapova says she has failed a drug test at the Australian Open. (AP Photo/Damian Dovarganes)

Reuters reports that the medicine Maria Sharapova says she has taken for 10 years due to a family history of heart issues and diabetes is an old drug sold in just a few Eastern European countries that can also boost exercise tolerance.

The tennis star tested positive for the banned drug meldonium, or Mildronate, in a sample taken on Jan. 26, the day of her Australian Open quarter finals defeat by Serena Williams.

She said her family doctor had first given her the drug 10 years ago after she frequently became sick, had irregular electrocardiogram results, a magnesium deficiency and a family history of diabetes.

The 28-year-old Russian, a five-time grand slam champion and the highest paid woman in sports, will be provisionally suspended from March 12, the International Tennis Federation (ITF) said.

For the health conditions Sharapova says she has, however, doctors say the scientific evidence for Mildronate is limited compared with many medicines widely available in Europe and the United States, where Sharapova trains, which have full regulatory backing and years of robust safety and efficacy data.

LATVIAN DRUG

Meldonium is cheap and available over the counter without a prescription in some eastern European countries, where it is marketed as Mildronate by the Latvian pharmaceutical firm Grindeks.

The drug, originally developed by scientists at the Latvian Institute of Organic Synthesis, is not licensed by two of the world's biggest medicines regulators: the Food and Drug Administration (FDA) in the United States and the EU's European Medicines Agency.

A spokeswoman for Grindeks said the firm had not applied for a licence for Mildronate from either the FDA or the EMA, but the drug is registered in Latvia, Lithuania, Russia and other countries of the former Soviet Union.

She said it is designed to treat patients with certain cardiovascular diseases, including angina, chronic heart failure, cardiomyopathy and other cardiovascular disorders.

Grindeks' also promotes it for people with reduced working capacity due to physical or psycho-emotional "overload", and during recovery from cerebrovascular disorders, head injury and encephalitis. It is not indicated for diabetes.

A box of meldonium tablets, also known as mildronate, is photographed in Moscow, Tuesday, March 8, 2016. Russian tennis star Maria Sharapova says she failed a drug test for meldonium at the Australian Open. The drug was only banned in January and there has been a string of failed tests by athletes in several sports since. (AP Photo/Harriet Morris)

Tim Chico, a consultant cardiologist at Britain's Sheffield University, said it was unlikely that such a young and extremely fit woman would be suffering from a serious heart condition like angina, or would be able to play top level tennis if she were.

Asked how long the drug should be given to a patient, the Grindeks spokeswoman said in an emailed statement: "Depending on the patient health condition, treatment course of meldonium preparations may vary from 4 to 6 weeks". Such courses could be repeated two or three times in a year.

In an emailed reply to questions from Reuters about her medical reasons for using the drug, Sharapova's lawyer John Haggerty said: "While I cannot go into detail out of respect for the ITF process, I can confirm that Ms Sharapova had abnormal EKG tests in 2006 and was also diagnosed with asthenia (a lack of energy or strength), decreased immunity and diabetes indicators."

"She also had a family history of heart conditions," Haggerty said. "The Mildronate and the other medicines recommended by her doctor treated these conditions."

Latvia expressed sadness over the banning of the drug.

"It's sad that there is such a situation, that this drug has been banned," said a spokesman for Prime Minister Maris Kucinskis. "Especially given that is one of the most significant accomplishments of Latvian scientists in general."

Ivars Kalvins invented the drug in the 1970s when Latvia was still a Soviet republic. He told a local newspaper in 2009 that it had been used to boost troops' fighting stamina in the 1980s. At that time Soviet forces were in Afghanistan.

Kirovs Lipmans, chairman of Grindeks, said use of the drug did not constitute doping and criticised the government for not defending its reputation.

Munir Pirmohamed, a professor of molecular and clinical pharmacology at Britain's University of Liverpool, said the crucial issue with Mildronate for him is its lack of approval from EU and U.S. regulators.

"As a physician, this is not something I have, or would ever, prescribe," he said.

Others noted it was rare for a doctor treating illness to prescribe a drug that is unavailable in the country where the patient lives.

"Sharapova has been a U.S. resident since early in her career, which does bring in a question of how or why she is using a drug that is not licensed there," said Tom Bassindale, a lecturer in forensic science at Sheffield Hallam University.

Sharapova's agent Max Eisenbud was not available at his Miami office and did not immediately reply to an email seeking comment.

HELPS MUSCLES COPE

Whatever its medical benefits, research suggests Mildronate may have potential as a performance-enhancing drug for sports.

It reduces the level of a metabolite called carnetine in muscles, and by doing that helps muscles cope better with high levels of stress and low oxygen levels.

"Because it effects the cellular metabolism, it would increase energy production within cells and therefore make oxygen utilisation more efficient," said Pirmohamed.

In a 2010 academic paper published in a review journal called Seminars in Cardiovascular Medicine and cited on the Grindeks company website, it has been shown to improve exercise tolerance in patients with heart problems.

The World Anti-Doping Agency, which banned the drug in January after previously having it on a "watch list", ranks it as a prohibited metabolic modulator and cites "evidence of its use by athletes with the intention of enhancing performance".

Grindeks says the drug could protect athletes from cell damage, but it would be unlikely to improve their competitive performance.

It would be "reasonable to recommend (sports people) to use meldonium as a cell protector to avoid heart failure or muscle damage in case of unwanted overload," the spokeswoman said.

Athletes "should not expect increase of physical capacity, but, for sure, they will be protected against ischemic damages of cells in case of overload."